Learning DisorderNCT05803278
Online Screening and Empowerment Program for Children With SLD
A study testing Online enhancement training in people with Learning Disorder, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
One of the problems faced by health services that deals with the diagnosis and treatment of Specific Learning Disorders (SLD), like Dyslexia, Dysgraphia, Dysorthography and Dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. Read more about this study
- Who is it for?
- Ages 7 to 8 years
- Conditions the study is for
- Learning Disorder
- What is being tested?
- Online enhancement training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,548 participants
- Where
- 1 siteItaly
- Study dates
- 9 Feb 2021to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children attending the second year of the primary school (about 7-8 years of age)
Who cannot join
- Presence of biological problems associated to school difficulties
- Low cognitive level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of an Online Screening and Empowerment Program Carried Out at Schools to Identify Children With Specific Learning Disorders
One of the problems faced by health services that deals with the diagnosis and treatment of Specific Learning Disorders (SLD), like Dyslexia, Dysgraphia, Dysorthography and Dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. One of the reasons explaining the long waiting times is that the school refers a large number of children to the hospital services who do not actually have SLD but a simple school difficulty. These two are very different conditions:
- SLD is a neurobiological and genetic-based disorder that, with various degrees of severity, lasts a lifetime. Epidemiological data of the FVG region report a prevalence of dyslexia of 3.1%. Therefore, a prevalence of SLD between 4 and 5% can be assumed. This is a condition whose expressiveness cannot be modified by an enhancement intervention;
- The school difficulties are not innate and are characterized by an initial slowdown in bed-writing learning. The prevalence of low-performance school difficulties is between 10 and 15%. This type of problem improves significantly following specific enhancement.
Read more
Resistance to enhancement intervention is precisely one of the criteria that is still used to distinguish a school difficulty from a SLD: students with SLD would be those who show resistance to specific educational interventions. This criterion is based on the assumption that SLD has a precise neurofunctional basis in contrast to school difficulties. These are a transitional condition, which can be modified by didactic adaptations and enhancement activities (Law 170/2010; regional resolution 933/2014 FVG).
The application of enhancement tools in the school environment would therefore make it possible to distinguish, on the basis of the response, subjects with simple school difficulties from those with suspected SLD and, therefore, to report just those one, to the health services for diagnostic confirmation, contributing to the reduction of the workload of the hospital services and the reduction of waiting lists. These results are very important for children with SLD who could be identified and treated in an early and timely manner. The aim of this project is to apply an online screening and further school enhancement process using the "InTempo software" to distinguish children with SLD from those with school difficulties, thus also obtaining data on the real incidence of SLD and school difficulties in The Friuli Venezia Giulia Region.
- Conditions
- Learning Disorder
- Being tested
- Online enhancement training
- Keywords
- Specific Learning Disorders, Screening, Online enhancement
- Medical subject headings
- Learning Disabilities, Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online enhancement trainingOther
Online enhancement training lasting 3 months, using the "InTempo" app system (Gea-Metaphonology-Athena-reading/Ermes-writing) three times a week for twenty minutes. The training will include: Metaphonological Enhancement; Reading Enhancement; Writing Enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Children positive to screening test | Experimental | Children positive to the online test "InTempo", which includes standardized and scientifically validated tests in the following areas: Metaphonology, Reading and Writing Receives: Other: Online enhancement training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SLD
The first screening test and the subsequent enhancement training for positive will be carried out on-line in school children aged 7-8 years. Children without improvement after enhancement training (second screening test) will be considered positive (presence of SLD) and sent to the health services for a specific diagnostic evaluation.
Measured: 6 months
Secondary outcomes (2)
To evaluate the prevalence of school difficulties
Defined by positivity at the first screening test and by negativity at the second, carried out after the enhancement intervention
Measured: 6 months
To compare the Strengths and Difficulties Questionnaire scores recorded during the study
The Strengths and Difficulties Questionnaire (italian version) will be administered to parents of the children involved in the study pre and post intervention to evaluate emotional and behavioural characteristics of the children and to assess how they change during the enhancement process.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start9 Feb 2021
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,548 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabella Lonciari, MSC, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803278
- Sponsor's protocol ID
- RC 23/20
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of an Online Screening and Empowerment Program Carried Out at Schools to Identify Children With Specific Learning Disorders
- ClinicalTrials.gov ID
- NCT05803278
- Acronym / sponsor ID
- RC 23/20
- Conditions
- Learning Disorder
- Keywords
- Specific Learning Disorders, Screening, Online enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,548 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the problems faced by health services that deals with the diagnosis and treatment of Specific Learning Disorders (SLD), like Dyslexia, Dysgraphia, Dysorthography and Dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. One of the reasons explaining the long waiting times is that the school refers a large number of children to the hospital services who do not actually have SLD but a simple school difficulty. These two are very different conditions:
- SLD is a neurobiological and genetic-based disorder that, with various degrees of severity, lasts a lifetime. Epidemiological data of the FVG region report a prevalence of dyslexia of 3.1%. Therefore, a prevalence of SLD between 4 and 5% can be assumed. This is a condition whose expressiveness cannot be modified by an enhancement intervention;
- The school difficulties are not innate and are characterized by an initial slowdown in bed-writing learning. The prevalence of low-performance school difficulties is between 10 and 15%. This type of problem improves significantly following specific enhancement.
Resistance to enhancement intervention is precisely one of the criteria that is still used to distinguish a school difficulty from a SLD: students with SLD would be those who show resistance to specific educational interventions. This criterion is based on the assumption that SLD has a precise neurofunctional basis in contrast to school difficulties. These are a transitional condition, which can be modified by didactic adaptations and enhancement activities (Law 170/2010; regional resolution 933/2014 FVG).
The application of enhancement tools in the school environment would therefore make it possible to distinguish, on the basis of the response, subjects with simple school difficulties from those with suspected SLD and, therefore, to report just those one, to the health services for diagnostic confirmation, contributing to the reduction of the workload of the hospital services and the reduction of waiting lists. These results are very important for children with SLD who could be identified and treated in an early and timely manner. The aim of this project is to apply an online screening and further school enhancement process using the "InTempo software" to distinguish children with SLD from those with school difficulties, thus also obtaining data on the real incidence of SLD and school difficulties in The Friuli Venezia Giulia Region.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children positive to screening test | Experimental | Other: Online enhancement trainingChildren positive to the online test "InTempo", which includes standardized and scientifically validated tests in the following areas: Metaphonology, Reading and Writing |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children attending the second year of the primary school (about 7-8 years of age)
Key exclusion criteria (2 listed)
- Presence of biological problems associated to school difficulties
- Low cognitive level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online enhancement trainingOnline enhancement training lasting 3 months, using the "InTempo" app system (Gea-Metaphonology-Athena-reading/Ermes-writing) three times a week for twenty minutes. The training will include: Metaphonological Enhancement; Reading Enhancement; Writing Enhancement. | Other | Children positive to screening test |
Primary outcome
Prevalence of SLD
Time frame: 6 months
The first screening test and the subsequent enhancement training for positive will be carried out on-line in school children aged 7-8 years. Children without improvement after enhancement training (second screening test) will be considered positive (presence of SLD) and sent to the health services for a specific diagnostic evaluation.
2 secondary outcomes
To evaluate the prevalence of school difficulties
Time frame: 6 months
To compare the Strengths and Difficulties Questionnaire scores recorded during the study
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Learning Disorder
Active, not recruiting
High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
Evaluating the Impacts of Informal Tick and Tickborne Disease Educational Tools on Children
Tick Bites
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Active, not recruitingPhase 2
A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
Alport Syndrome
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Lonciari, MSC study director
IRCCS materno infantile Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online enhancement training in people with Learning Disorder, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SLD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.